FDA 483 - Leading Pharma, LLC - October 21, 2024

Leading Pharma, LLC in Fairfield, NJ, was inspected and received a Form 483 with five observations related to significant deficiencies in their manufacturing and quality control processes. The inspection revealed failures in establishing adequate production controls, conducting bulk hold time studies, investigating discrepancies, validating test methods, and ensuring data integrity through audit trail reviews. These issues indicate a systemic lack of control over critical aspects of drug product quality and data management.